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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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Eversense CGM Non-Adjunctive PAS


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General
Study Status Progress Adequate
Application Number P160048 S006/ PAS001
Date Current Protocol Accepted  
Study Name Eversense CGM Non-Adjunctive PAS
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Device Subjects Serve as Own Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The purpose of this post-approval study (PAS) is to evaluate the safety of non-adjunctive use of the Senseonics Eversense Continuous Glucose Monitoring (CGM) System relative to the use of glucose meters. This is a one-year prospective cross-over study in which all subjects will use a glucose meter (SMBG arm) for a 6-month period followed by 6 months of using the Eversense CGM System (CGM arm).



Study Population Description Subjects may be included in the PAS if they fit the following inclusion criteria:

1. Subject has diabetes mellitus (type 1 or type 2)

2. Subject is greater than 18 years of age



Subjects may not be included in the PAS if they fulfill the following exclusion criteria:

1. Subjects have significant prior CGM experience defined as more than one week of continuous use in the past 6 months, or more than four consecutive weeks in a twelve month period or twelve weeks total use in the past three years (not including use of professional CGMs).

2. Subject is critically ill or hospitalized

3. Subject has a known contraindication to dexamethasone or dexamethasone acetate

4. Subjects requiring intravenous mannitol or mannitol irrigation solutions

5. Female subjects who are pregnant, planning on becoming pregnant or nursing

Sample Size Up to 925 subjects will be enrolled in the United States at up to 60 sites.



Data Collection The primary safety endpoint is the rate of the composite of severe hypoglycemia and diabetic ketoacidosis.



Other safety endpoints include:

Rate of all device-related and insertion and removal procedure-related adverse events

Rate of adverse events related to use of the user interface, patient training, or labeling materials.

Change in HbA1c from baseline at 6 and 12 months

Average hours of use per day

Serious adverse events regardless of causality



Follow-up Visits and Length of Follow-up Patients will participate for up to 12 months (6 months in each of two study arms)


Eversense CGM Non-Adjunctive PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 12/05/2019 12/06/2019 On Time
one year report 06/05/2020 06/05/2020 On Time
18 month report 12/04/2020    
two year report 06/05/2021    
three year report 06/05/2022    
four year report 06/05/2023    
five year report 06/04/2024    


Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

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